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A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART) (EP1090)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Epimmune.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Pharmexa A/S
Pharmexa-Epimmune
Information provided by:
Epimmune
ClinicalTrials.gov Identifier:
NCT00532974
First received: September 19, 2007
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.


Condition Intervention Phase
HIV Infections
 Biological: EP1090
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Epimmune:

Primary Outcome Measures:
  • Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms. [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: October 2006
Estimated Study Completion Date: April 2008
Intervention Details:
    Biological: EP1090
    Low dose
    Biological: EP1090
    High dose
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 Infection
  • CD4 Tcell count >350
  • HIV-1 RNA levels to <400 copies
  • Negative HbsAg and anti-HCV antibody

Exclusion Criteria:

  • Recent receipt of experimental HIV-1 vaccines
  • Recent use of immunomodulatory agents
  • Hypersensitivity or serious reactions to study vaccine components
  • Active opportunistic infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532974

Locations
United States, California
AIDS Research Alliance
West Hollywood, California, United States, 90069
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
Epimmune
Pharmexa A/S
Pharmexa-Epimmune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00532974     History of Changes
Other Study ID Numbers: EP-HIV-1090
Study First Received: September 19, 2007
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Epimmune:
HIV
Human Immunodeficiency Virus
Vaccines
HIV Vaccines
 Peptide
Peptide Vaccines
HIV 1

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013